Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products Text with EEA relevance

Article 1

The uniform principles for evaluation and authorisation of plant protection products provided for in Article 29(6) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

GENERAL INTRODUCTION

1. GENERAL PRINCIPLES

1.1.The objective of the principles developed in this Annex is to ensure a high level of protection of human and animal (species normally fed and kept by humans or food-producing animals) health and the environment in evaluations and decisions by Member States with regard to authorisation of plant protection products, implementing the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(1)(f), (g) and (h) of Regulation (EC) No 1107/2009. For the purpose of this Annex, the following definitions apply:

(1) ‘efficacy’ means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance, phytotoxicity or reduction of qualitative or quantitative yield);

(2) ‘relevant impurity’ means a chemical impurity that is of concern for human health, animal health or the environment;

(3) ‘storage stability’ means the capacity of a plant protection product to maintain the initial properties and the specified content during the storage period under established storage conditions.

1.2.In evaluating applications for granting authorisations Member States shall:

(a) — ensure that dossiers supplied are in accordance with the requirements of the Annex to Commission Regulation (EU) No 284/2013 (¹), at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009, — ensure that the data submitted by the applicant are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, — evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

(b) take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 283/2013 (²), submitted for the purpose of approval of the active substance under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 33(3) and of Articles 34 and 59 of Regulation (EC) No 1107/2009;

(c) take into consideration other relevant technical or scientific information with regard to the efficacy of the plant protection product or to the potentially adverse effects of the plant protection product its components or its residues, where relevant.

1.3.Where, in the specific principles on evaluation, reference is made to the data of the Annex to Regulation (EU) No 283/2013 this shall be understood as being the data referred to in point 1.2(b) of this Annex.

1.4.Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, Member States shall evaluate applications and make a decision for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

1.5.During the process of evaluation and decision-making, Member States shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a technically complete dossier that allows for a proper evaluation, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full compliance with the requirements of this Annex and more generally with the provisions of Regulation (EC) No 1107/2009.

1.6.During the process of evaluation and decision-making, Member States shall base their assessment on scientific principles, preferably recognised at international level, and this process shall be made with the benefit of expert advice.

1.7.Member States shall take into account those guidance documents applicable at the date of the submission of the application for the authorisation.

2. EVALUATION, GENERAL PRINCIPLES

2.1.Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in point 1.2, and in particular:

(a) identify the risks arising, assess their significance and the expected exposure, and make a judgement as to the likely risks to humans, animals or the environment;

(b) assess efficacy in terms of effectiveness (including possible development of resistance or cross-resistance of the target organism(s)) and adverse effects (including phytotoxicity/pathogenicity) on crops (including treated crops, succeeding crops and adjacent crops) of the plant protection product for each use for which authorisation is sought.

2.2.Member States shall evaluate the quality and the methodology of tests, especially where there are no standardised test methods, as well as the following characteristics of the methods described, when available:

relevance; representativeness; sensitivity; specificity; reproducibility.

2.3.In interpreting the results of evaluations, Member States shall take into consideration and report possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.

2.4.In accordance with Article 29 of Regulation (EC) No 1107/2009, Member States shall ensure that evaluations carried out have regard to the proposed practical conditions of use and, in particular, to the purpose of use, the application dose, the application method, frequency and timing of applications, and the nature and composition of the plant protection product.

In accordance with the requirements for proper use as set out in Article 55 of Regulation (EC) No 1107/2009, Member States shall take into account the provisions of Directive 2009/128/EC of the European Parliament and of the Council (³) and, in particular, the principles of integrated pest management.

2.5.In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.

2.6.Where specific principles in Section 1 of Part A or Section 1 of Part B (as applicable) provide for the use of calculation models in the evaluation of a plant protection product, those models shall:

(a) make a best possible estimation in an appropriate way of all relevant processes involved taking into account realistic parameters and assumptions;

(b) be submitted to an evaluation as referred to in point 2.3;

(c) be reliably validated with measurements carried out under circumstances relevant for the use of the model;

(d) be relevant to the conditions in the area of use;

(e) in cases the models have not been validated, be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.

2.7.Where metabolites are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consideration. For Part A this concerns also degradation or reaction products. For Part B this concerns what is defined as ‘metabolites of concern’.

3. DECISION-MAKING, GENERAL PRINCIPLES

3.1.Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions shall be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.

3.2.Member States shall ensure that decisions taken to grant authorisations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and in authorisation being granted for some but not other areas within the Member State in question.

3.3.Member States shall ensure that the authorised application rates and number of applications, are the minimum necessary to achieve the desired effect even where higher rates would not result in unacceptable risks to human or animal health or to the environment. The authorised rates shall be differentiated in accordance with, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the application rates and the number of applications may not give rise to undesirable effects such as the development of resistance in the target organism.

3.4.Member States shall ensure that decisions taken to grant authorisations consider integrated pest management as set out in Directive 2009/128/EC. In particular, Member States shall ensure that a warning phrase is indicated on the label in case negative effects are expected on beneficial organisms that are deliberately released as part of integrated pest management strategies.

3.5.Since the evaluation is to be based on data concerning a limited number of representative non-target species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.

3.6.Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:

(a) fulfils the requirements setting out in Regulation (EU) No 547/2011;

(b) also contains the information on protection of operators, workers, bystanders and residents required by EU legislation on worker protection;

(c) specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 3.1 to 3.5 of this general introduction.

The authorisation shall mention the particulars indicated in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (⁴).

3.7.Before issuing authorisations, Member States shall:

(a) ensure that the proposed packaging is in accordance with the provisions of Regulation (EC) No 1272/2008;

(b) ensure that the following procedures are in accordance with the relevant regulatory provisions: — the procedures for destruction of the plant protection product, — the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and — the procedures for the decontamination and destruction of the packaging.

3.8.No authorisation shall be granted unless all the requirements referred to in Section 2 of Part A or Section 2 of Part B (as applicable) are satisfied. However:

(a) when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 of Part A, or point 2.3 of Part B, respectively, are not satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the aforementioned requirements must be mentioned on the label, and non-compliance with the requirements referred to in point 2.7 of Part A (if Part A applies) shall not compromise proper use of the plant protection product. These advantages can be in terms of: — advantages for and compatibility with integrated control measures or organic farming, — facilitating strategies to minimise the risk of development of resistance, — the need for a greater diversity of types of active substances or biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil, — reduced risk for operators and consumers, — reduced contamination of the environment and reduced impact on non-target species.

(b) where the criteria referred to in point 2.6 of Part A or point 2.4 of Part B, respectively, are not fully satisfied because of limitations in current analytical science and technology, authorisation shall be granted for a limited period if the methods submitted prove adequate for the purposes intended. In this case, the applicant shall be required to develop and submit analytical methods that are in accordance with those criteria by a specific deadline. The authorisation shall be reviewed on expiry of that deadline;

(c) where the reproducibility of the submitted analytical methods referred to in point 2.6 of Part A or point 2.4 of Part B, respectively has only been verified in two laboratories, an authorisation shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria in at least a third laboratory.

3.9.Where an authorisation has been granted in accordance with the requirements provided for in this Annex, Member States may, by virtue of Article 44 of Regulation (EC) No 1107/2009:

(a) define, where possible, preferably in close cooperation with the applicant, measures to improve the efficacy of the plant protection product; and/or

(b) define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.

Member States shall inform applicants of any measures identified under (a) or (b) and shall require applicants to provide any supplementary data and information necessary to demonstrate efficacy or acceptability of risks arising under the changed conditions.

3.10.Member States shall ensure, as far as it is practically possible, that for all active substances contained in plant protection products that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in scientific literature at the time of submission of the dossier on the plant protection product.

PART A

Uniform principles for evaluation and authorisation of chemical plant protection products

1. EVALUATION

Member States shall, for the evaluation of the data and information submitted in support of applications, and without prejudice to the general principles of Section 2 of the general introduction, implement the following principles.

1.1.1.Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use.

1.1.2.Where the proposed use concerns an effect other than the control of or protection against an organism, Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used.

1.1.3.Member States shall evaluate the efficacy data on the plant protection product as provided for in the Annex to Regulation (EU) No 284/2013 having regard to the degree of control or the extent of the effect desired and having regard to the relevant experimental conditions such as:

— the choice of the crop or cultivar,

— the agricultural and environmental (including climatic) conditions,

— the presence and density of the harmful organism,

— the development stage of crop and organism,

— the amount of the plant protection product used,

— if required on the label, the amount of adjuvant added,

— the frequency and timing of the applications,

— the type of application equipment.

1.1.4.Member States shall evaluate the performance of the plant protection product in a range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use and in particular:

(i) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control;

(ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products and an untreated control.

Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.

1.1.5.Where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 1.1.1 to 1.1.4 in relation to the information supplied for the tank mix.

Where the product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use.

1.2.1.Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product in accordance with the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.

(a) This evaluation shall take into consideration the following information: (i) the efficacy data provided for in the Annex to Regulation (EU) No 284/2013; (ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; (iii) all relevant information on the active substance as provided for in of the Annex to Regulation (EU) No 283/2013, including mode of action, vapour pressure, volatility and water solubility.